- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354691
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
A 6-Month Prospective, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Adaptive-Trial-Design Study to Evaluate the Safety and Efficacy of 80mg b.i.d Ladostigil in Patients With Mild to Moderate Probable Alzheimer's Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Graz, Austria, 8036
- Medizinische Univeritat Graz, Universitatsklinik fur Neurologie, Auenbruggerplatz 22
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Horn, Austria, 3580
- Privatordination Horn, HamerlingstraBe 15
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Linz, Austria, 4020
- Allgemeines Krankenhaus der Stadt Linz, KrankenhausstraBe 9
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Wein, Austria, 1130
- Privatordination, Lainzerstrasse 20
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Pula, Croatia, 52100
- General Hospital Pula, Negrijeva 6
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Zabok, Croatia, 49210
- General Hospital Zabok, Bracak 8
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Zagreb, Croatia, 10000
- Clinical Hospital Center Zagreb, Kispaticeva 12
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Zagreb, Croatia, 10000
- Clinical Hospital Dubrava, Avenija Gojka Suska 6
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Zagreb, Croatia, 10000
- Polyclinic Neuron, Salata 12
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Zagreb, Croatia, 10090
- Psychiatric Hospital Vrapce, Bolnicka cesta 32
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Hamburg, Germany, 20253
- Klinische Forschung Hamburg GmbH, Hoheluftaussee 18
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Schwerin, Germany, 19055
- Klinische Forschung Schwerin GmbH, FriedrichstraBe 1
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Westerstede, Germany, 26655
- Studienzentrum Nordwest, Lange StraBe 23-25
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Belgrad, Serbia, 11000
- Clinical Centre of Serbia, Dr. Subotica 6
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Belgrade, Serbia, 11000
- Military Medical Academy, Crnotravska 17
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Algorta, Spain, 48993
- CAE Oroitu Centro Atencion Especializada C/Jata, 9
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Barcelona, Spain, 08004
- Centro Geroinnova Barcelona, Calle Mandoni n 17
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Barcelona, Spain, 08014
- Fundacio ACE, Institut Catala de Neurosciencies Aplicadas, C/Margues de Sentmenat 35-37
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Salt, Spain, 17190
- Institud d' Assistencia Sanitaria de Girona, Edifici La Republica - C/Dr. Castany, s/n
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AD diagnosis according to NINCDS-ADRDA criteria
- Mild to moderate AD according to MMSE 14-24 inclusive
- MRI or CT assessment within 6 months before baseline, corroborating the clinical diagnosis and excluding other potential causes of dementia especially cerebrovascular lesions
- Absence of major depressive disease according to CSDD of less than or equal to 18
- Modified Hachinski Ischemic Scale equal to or below 4
- Education for eight or more years
- Previous decline in cognition for more than six months as documented in patient medical records
- A caregiver available and living in the same household or interacting with the patient daily and available if necessary to assure administration of investigational product
- Patients living at home or nursing home setting without continuous nursing care
- General health status acceptable for participation in a 12-month clinical trial and ability to swallow oral medication
- No history of treatment with rivastigmine
- For patients with either donepezil or galantamine anti-cholinesterase inhibitor treatment prescribed, stopped treatment four weeks prior to screening
- For patients with memantine treatment prescribed, stopped treatment four weeks prior to screening
Exclusion Criteria:
- Other primary degenerative dementias (e.g. dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Jacob-Creutzfeldt disease)
- Other neurodegenerative conditions (Parkinson's disease. amyotrophic lateral sclerosis, etc)
- Other central nervous system diseases (severe head trauma, tumors, subdural hematoma, etc)
- A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
- Seizure disorders
- Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc)
- Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations
- Other unstable, chronic or clinically significant medical conditions involving major organs like kidney, liver, lungs and heart/vasculature
- Hospitalization or change of chronic concomitant medications one month prior to screening or during screening period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo capsules
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Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths.
Oral, solid dosage.
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Experimental: ladostigil hemitartrate
Ladostigil capsules 80 mg
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Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths.
Oral, solid dosage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
Time Frame: 26 weeks
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Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test. |
26 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Neuropsychiatric Inventory (NPI)
Time Frame: 52 weeks
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The Neuropsychiatric Inventory (NPI) was developed to assess psychopathology in dementia patients.
It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities.
The severity and frequency of each neuropsychiatric symptom are rated on the basis of scripted questions administered to the patient's caregiver.
Higher the score the more disturbed, lower score is thus better.
Minimum score is 0 and maximum is 80.
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52 weeks
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Cornell Scale for Depression in Dementia (CSDD)
Time Frame: 52 weeks
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The Cornell Scale for Depression in Dementia (CSDD) was developed specifically to assess signs and symptoms of major depression in dementia on the basis of a semi-structured interview of a qualified informant.
The CSDD evaluates a broad spectrum of depressive signs and synptoms and includes items from other depression scales.
Information is obtained from interview of the caregiver as well as from direct observation and interview of the patient CSDD is a 19 item scale assessing depressive status.
Higher score more depression.
The scale ranges from 0-no depression to 38 maximum depression.
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52 weeks
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Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 52 weeks
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The Activities of Daily Living ADCS-ADL is a caregiver-based ADL scale composed of 23 items developed for use in dementia clinical trials.
It is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests as well as making judgments and decisions.
For each ADL, the caregiver is asked whether the patient attempted the activity during the past four weeks.
If the answer is positive, the caregiver is then asked to choose the single most accurate definition of the patient's level of performance.
Assessment of functional activity status is a 23 item scale measuring impairment in functioning.
The scale total score ranges from 0-profound impairment to 30 normal functioning (no impairments)
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52 weeks
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Mini-Mental State Examination
Time Frame: 52 weeks
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The MMSE is a frequently used screening instrument for AD drug studies.
The instrument provides for evaluation of orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence and to copy two intersecting polygons.
This examination is frequently used by physicians in the original diagnosis of AD, and in its subsequent progression, because it can be easily performed in the routine care of patients.
A lower score indicates more cognitive impairment.
The highest (best) score is 30.
The Mini-Mental State Examination, MMSE, is a 30-point questionnaire measures cognitive impairment to screen for dementia.
Items are totaled.
The scale ranges from 0-most impairment to 30 (normal) no impairment.
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52 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reinhold Schmidt, MD, Medizinische Universität Graz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Cognition Disorders
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Memory Disorders
- Amnesia
Other Study ID Numbers
- CR100101/CO15570
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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